A-Pharma long experience in clinical trials and pharmacovigilance practices guarantee high quality, reliability and regulatory compliance in reporting to EMEA, national agencies, concerned ethics committees, and investigators on time.
You can rely on our professional services covering:
- reporting and processing of Serious Adverse Events (SAE)
- processing and reporting of Adverse Drug Reactions (ADRs)
- preparation and submission of Annual Safety Report (ASR) and Periodic Safety Update Reports (PSUR)
- safety and pharmaco-epidemiological studies
- global database pooling and integrated summaries of safety
- consulting and system analysis